What the label lists and what reports show

Vinblastine side effects

Vinblastine's FDA label: “Leukopenia, the most common adverse reaction, is usually the dose-limiting factor.” FAERS holds 1,941 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (170 reports).

Generic listed
Boxed warning

Check it at the source: the vinblastine FDA label on DailyMed (effective April 15, 2025, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
Leukopenia, the most common adverse reaction, is usually the dose-limiting factor.

From the label: adverse reactions, continued
Prior to the use of the drug, patients should be advised of the possibility of untoward symptoms. In general, the incidence of adverse reactions attending the use of vinblastine sulfate appears to be related to the size of the dose employed. With the exception of epilation, leukopenia and neurologic side effects, adverse reactions generally have not persisted for longer than 24 hours. Neurologic side effects are not common; but when they do occur, they often last for more than 24 hours. Leukopenia, the most common adverse reaction, is usually the dose-limiting factor. The following are manifestations that have been reported as adverse reactions, in decreasing order of frequency. The most common adverse reactions are underlined: Hematologic - Leukopenia (granulocytopenia), anemia, thrombocytopenia (myelosuppression). Dermatologic - Alopecia is common. A single case of light sensitivity associated with this product has been reported. Gastrointestinal - Constipation, anorexia, nausea, vomiting, abdominal pain, ileus, vesiculation of the mouth, pharyngitis, diarrhea, hemorrhagic enterocolitis, bleeding from an old peptic ulcer and rectal bleeding. Neurologic - Numbness of digits (paresthesias), loss of deep tendon reflexes, peripheral neuritis, mental depression, headache, convulsions. …

Source: FDA drug label, Fresenius Kabi USA, LLC, effective April 15, 2025 (SPL set f073b58e-56d6-4c8d-a2ce-b37719402d77), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,941 reports list vinblastine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 274 are coded as a death and 776 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Febrile Neutropenia170
Neutropenia150
Pyrexia124
Nausea (named in the label)86
Vomiting (named in the label)79
Pulmonary Toxicity78
Neuropathy Peripheral75
Neutrophil Count Decreased75
Pancytopenia75
Off Label Use (a use or a product term, not a reaction)74
Anaemia (named in the label)71
Sepsis70
White Blood Cell Count Decreased66
Dyspnoea (named in the label)65
Diarrhoea (named in the label)60
Interstitial Lung Disease58
Disease Progression (a use or a product term, not a reaction)55
Abdominal Pain (named in the label)51
Pneumonia42
Mucosal Inflammation41
Thrombocytopenia (named in the label)37
Fatigue36
Asthenia35
Constipation (named in the label)34
Hodgkin^S Disease33

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Vinblastine: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions